mastercontrol supplier deviation™
DESCRIPTION
The supply chain for FDA-regulated companies poses many challenges. Suppliers are considered an extension of the company and thus must be shown to be FDA-compliant themselves. They have to be evaluated, audited and monitored. Their shipments have to be tested for compliance with a material’s specifications. Under very specific circumstances, exceptions from the written specifications can be made after appropriate review by the quality and engineering departments. However, waiting for this assessment until after the shipment has arrived at your loading dock puts undue pressure on your quality department and creates unnecessary costs in the event that a delivery is declined.TRANSCRIPT
MasterControl Supplier™
phone: 800.825.9117 web: www.mastercontrol.com email: [email protected]
MasterControl Supplier™
Vendors providing goods and services to companies doing business in regulated environments are only qualified to supply specific products and services. As such, these suppliers must be accurately tracked on a company’s approved vendor list (AVL). The AVL must be continually managed and monitored, a complex process that becomes exponentially more difficult as product designs and manufacturing processes change over time. Further complexities arise as increasing numbers of suppliers interface with or are managed by different departments and divisions across the company.
How can MasterControl help you? Here’s how MasterControl Supplier™ is giving companies the capability to efficiently manage and approve vendor lists and effectively track supplier quality and supplier status.
Challenges MasterControl SolutionTracking AVL manually: Maintaining and controlling an approved vendor list is complex and error prone, particularly when supplier quality information is kept in separate systems or tracked manually via spreadsheets.
Centralized, connected system: With MasterControl, all supplier status and quality information (such as non-conforming material reports) is automatically contained in a single, easy to access location. In addition to providing an easily maintainable AVL, MasterControl Supplier features a user-friendly interface for accessing all documentation and records related to each supplier.
Complications with new parts and manufacturers: As engineering teams develop new designs, contract manufacturers and parts must be identified and added to the AVL. To be placed on the AVL, a supplier must be monitored on an ongoing basis and must successfully fulfill a number of qualifications, such as supplier surveys, supplier audits, and process validation.
Automated tracking: MasterControl automatically tracks and stores supplier information derived from audits, non-conformance reports, supplier deviations, and CAPAs. This electronically managed information can then be easily compiled for supplier quality ratings. Furthermore, suppliers can be approved using MasterControl’s robust approval workflow technology.
Difficulty to add and track approved parts and suppliers: As new parts and suppliers are added and as suppliers’ approval status changes, accurate and current tracking of parts and suppliers becomes increasingly more elaborate and difficult.
Simplified adding and tracking of parts and suppliers: With MasterControl, goods or services can be added to the “approved to supply” list simply by linking the goods/services to a specific supplier in MasterControl. Suppliers, conversely, can be added the same way. If a part is linked to a supplier that is not approved, the link will be disabled until the supplier becomes approved or reapproved. All of this information is easily obtainable via MasterControl’s built-in reporting tool.
Duplication of supplier qualification efforts: As new goods and services are added and as suppliers’ approval status changes, accurate and current tracking of outsourced goodsand/or services becomes increasingly more elaborate and difficult.
Web-based platform: MasterControl’s Web-based platform makes accessing supplier data easy and efficient. Geographically dispersed divisions have the ability to share supplier qualification data with others in the corporation, potentially cutting out costly duplication of effort and speeding time to market.
MasterControl Supplier™
phone: 800.825.9117 web: www.mastercontrol.com email: [email protected]
Features and Benefits:
Connected System: • MasterControl securely maintains each supplier’s vital information—approval status, contact information, recent audits, non-conformances, CAPA reports, contracts, approved goods/services lists, supplier ratings, and links to analytics reports—in a single, centrally located repository.
Functionality: • MasterControl Supplier provides users with a variety of functionality options, including: creating new suppliers in the system, viewing lists of suppliers, searching for suppliers, and importing supplier information.
Reporting Capabilities: • MasterControl can run Approved Vendor reports that include lists of the goods or services a supplier is approved to supply, contact information for each supplier returned, and those supplier’s ratings. Reports can also be run for all suppliers, regardless of status. Furthermore, reports are available for tracking and trending supplier quality events such as CAPAs and deviations.
Simplified Status View: • The Supplier view in the MasterControl system displays a Supplier Status field for each supplier, indicating if that vendor is approved or not.
Bi-directional Links: • All goods/services and supplier links operate bi-directionally within MasterControl. The MasterControl system automatically checks approval status to determine which links should be marked as inactive or if they should be displayed at all.
Templates: • MasterControl users are able to configure templates to choose from based on the type of supplier being added. Similar to a MasterControl InfoCard Type, templates include custom fields and template options such as numbering series and lifecycle as well as dynamically filtered analytics reports and virtual folders.
Virtual Folders and Analytics Reports: • Default Virtual Folders and analytics reports can be set and new ones can be created and added. Virtual Folders can be previewed right in the window and then the full folder can be run from that point.
Dashboard Capability: • Virtual Folders and analytics reports can be embedded in the Supplier tab, essentially converting the supplier InfoCard into a dashboard. Users can configure the Supplier tab to include appropriate Virtual Folders and links to analytics reports.
About MasterControlMasterControl Inc. is a global provider of GxP process, quality audit, and document management software solutions for life science companies. MasterControl™ products are easy to use, easy to deploy, easy to validate, and easy to maintain. They incorporate industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. Hundreds of companies, including 50 percent of the top 20 pharmaceutical enterprises, currently use MasterControl solutions for easier compliance, faster validation, and better process management. For more information about MasterControl, visit www.mastercontrol.com or call: 800-825-9117 (U.S.); +44 1256 325 949 (Europe); or 03-6801-6147 (Japan).
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